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Ramucirumab plus paclitaxel as a second-line treatment in HER2-positive gastric cancer: subgroup analysis of a nationwide, real-world study in Korea (KCSG-ST19-16)

Authors
Kim, Bum JunJee, Hee-JungRha, Sun YoungHan, Hye SookRyu, Min-HeePark, Se HoonKim, Jong GwangBae, Woo KyunLee, Keun-WookOh, Do-YounByun, Ji-HyeKim, Dong SookSuh, Young JuAn, HyongginZang, Dae Young
Issue Date
May-2022
Publisher
Springer Verlag
Keywords
Stomach neoplasms; Ramucirumab; Paclitaxel; ErbB-2
Citation
Gastric Cancer, v.25, no.3, pp 609 - 618
Pages
10
Indexed
SCIE
SCOPUS
Journal Title
Gastric Cancer
Volume
25
Number
3
Start Page
609
End Page
618
URI
https://scholarworks.korea.ac.kr/kumedicine/handle/2020.sw.kumedicine/55286
DOI
10.1007/s10120-021-01276-4
ISSN
1436-3291
1436-3305
Abstract
Background A subgroup analysis of data from a nationwide study (KCSG-ST19-16) was performed to evaluate the efficacy and safety of second-line ramucirumab plus paclitaxel treatment in patients with human epidermal growth factor receptor 2 (HER2)-positive advanced gastric or gastro-esophageal junction (GEJ) adenocarcinoma. Methods The KCSG-ST19-16 study enrolled a total of 1063 patients from 56 hospitals in South Korea with advanced gastric or GEJ adenocarcinoma, who had received second-line treatment with ramucirumab plus paclitaxel. HER2 status was known for 994 (93.5%) of these patients, who were thus included in the subgroup analysis. Results In total, 163 of 994 patients (16.4%), had HER2-positive gastric or GEJ adenocarcinoma. The objective response rate to ramucirumab plus paclitaxel treatment was significantly higher in patients with HER2-positive disease compared to those with HER2-negative disease (23.0% [95% confidence interval (CI), 15.9–30.1] vs. 15.1% [95% CI, 12.3–17.9], p = 0.025). The median progression-free survival was longer in patients with HER2-positive versus HER2-negative disease, but the difference was not statistically significant (4.3 months [95% CI, 3.7–5.3] vs 3.7 months [95% CI, 3.4–4.0], p = 0.054). There was no statistically significant difference in median overall survival (OS) between the groups (9.8 months [95% CI, 8.9–12.3] vs 10.1 months [95% CI, 9.2–10.9], p = 0.564). Conclusions In patients with HER2-positive gastric or GEJ adenocarcinoma, the objective response rate to second-line treatment with ramucirumab plus paclitaxel was significantly higher compared to patients with HER2-negative disease. However, an increased response to treatment was not associated with an improvement in OS.
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